eligibility_summary
Eligibility: 18–75, life expectancy >3 mo, advanced/metastatic solid tumor after ≥1 prior line or no standard 1L, HER2 ≥30%, measurable lesion, tumor tissue (fresh preferred) and rebiopsy willingness, prior therapy ≥4 wk ago with ≤G1 toxicities, ECOG 0–2, adequate organs, prior PD-1/PD-L1 allowed, consent, contraception. Exclude: active autoimmune/CNS mets, steroids/immunosuppression, allergy, ILD, uncontrolled illness/substance abuse, HIV, pregnancy, other cancers (except select), vaccine, bleeding, unhealed wounds, other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: HypoSti.CAR‑HER2 T cells—autologous CAR‑T engineered with a hypoxia‑stimulated CAR expression system that increases CAR expression under low O2, enhancing T‑cell survival/expansion and tumor killing in hypoxic solid tumors, CAR specifically targets HER2/ERBB2. Preconditioning drugs: albumin‑bound paclitaxel (taxane microtubule stabilizer), cyclophosphamide (alkylating agent), and fludarabine (purine analog) for tumor debulking and lymphodepletion to improve CAR‑T engraftment. Cells/pathways targeted: HER2‑positive tumor cells, hypoxia/HIF‑responsive pathways in the tumor microenvironment, reduction of immunosuppressive host lymphocytes to counter TME-mediated suppression. Phase I/II, single-arm.